Thousands of ShopRite workers secure COVID-19 hazard pay

 Some essential workers are now getting the extra compensation they've been fighting for, as a local supermarket employee union announced it's reached a deal with a local grocery chain to pay its workers hazard pay during the pandemic.

The United Food and Commercial Workers International Union said Wednesday it's reached an agreement with ShopRite, giving nearly 50,000 union grocery workers in the tri-state area retroactive hazard pay. It includes all hours worked from July 26 to Aug. 22.

Earlier in the year, the union and ShopRite agreed to temporary hazard pay at the start of the pandemic.

The union said at least 109 grocery workers have died from COVID-19, and more than 48,000 have been infected or exposed.

“Grocery workers have been on the front lines since this pandemic began and continue to put themselves in harm’s way to help families put food on this Thanksgiving," UFCW International President Marc Perrone said. "This new UFCW agreement is a powerful victory for ShopRite grocery workers across New Jersey, New York, and Connecticut."

https://www.pix11.com/news/local-news/thousands-of-shoprite-workers-secure-covid-19-hazard-pay-with-new-union-deal

Does the AstraZeneca Vaccine Also Stop Covid Transmission?

 THREE MONDAYS IN a row have now yielded three apparently effective and safe vaccines against the pandemic disease Covid-19. Amid an unprecedented peak in cases in the United States and Europe, with US deaths pushing 250,000 and the country showing uncontrolled spread of the virus, that ain’t bad news.

But slightly hidden in that non-bad news was news even less bad. This week’s entrant, a vaccine from the drug company AstraZeneca and researchers at Oxford University, came with tantalizing hints of a particular capability that would, if it bears out, make a huge difference in fighting the pandemic. The makers of the two other vaccines in play have reported only evidence that their drugs keep people from getting sick—which is to say, fewer vaccinated people have moderate to severe symptoms and test positive for infection. The vaccines do this very well. But researchers working on the AstraZeneca version said they also had signs of reduced transmission, of people spreading the disease from one person to another. The AstraZeneca results have some perplexing elements, for sure, but if the transmission thing holds up, it’s going to matter. A lot.

Here’s what’s known (or at least announced) so far: The first two vaccines to complete their large-scale trials, one from the drug companies Pfizer and BioNTech and the other from Moderna, are a new kind of medicine. They use bits of genetic material called messenger RNA, in this case a sequence that codes for a part of the virus called a spike protein. That protein helps the SARS-CoV-2 virus attack people’s cells; the mRNA, enfolded in proprietary bubbles of fat, teaches the human immune system to fight the virus instead. Pfizer’s version has an efficacy of above 90 percent, says a company press release; a Moderna press release says its efficacy is 94.5 percent. If those results hold when more data becomes public, these vaccines would be extraordinary.

The one from AstraZeneca is a little more traditional, putting the gene for that spike protein into a sort of stealth carrier called a vector—in this case, an adenovirus that usually infects chimpanzees, modified so that it can’t replicate anymore. The company’s results—again, maddeningly, delivered via press release rather than peer-reviewed science—are a little more confusing. AstraZeneca is running different studies around the world, each with slightly different methodologies, which makes them hard to compare. But if you dump them all into the same pool, as AstraZeneca seems to have done, its two-dose regimen seems to have an efficacy of around 60 percent. That seems not great, though it’s higher than the 50 percent, plus or minus, that the US Food and Drug Administration was looking for. And in a group accidentally given a half-dose for the first shot and a full dose for the second, efficacy went up to 90 percent. Nobody knows why, and it is not good statistics to just average together a study done right with a study done wrong, re-analyzed after the fact.

But for the moment let’s not look this gift adenovirus in the mouth. The press release on the AstraZeneca vaccine from the Oxford side included this bulleted finding: “Early indication that vaccine could reduce virus transmission from an observed reduction in asymptomatic infections.” An Oxford immunologist told the news section of the journal Nature that some of the people in the UK part of the trial actually were testing themselves regularly for infection with the virus, and that different infection rates in the placebo and vaccine groups suggested that the drug was also blocking transmission of the disease. Researchers at Oxford also told reporters Monday that testing showed the vaccinated group in the UK had fewer asymptomatic infections, which means they'd be less likely to unwittingly spread the disease themselves.

Again: unpublished data, no details, no peer review, science-by-press-release. That ain’t good. But big, as political writers sometimes say, if true. People infected with the virus but without symptoms—asymptomatic spreaders—seem to be a reason the disease is pandemic-y. Nobody’s sure how big a reason, though.

Lots of other respiratory viruses overlap symptoms and transmission—sometimes the symptoms themselves, like coughing, are the way the virus gets from an infected person to others. The time between infection and symptoms, called the incubation period, doesn’t last long. “We know with flu, the incubation period is relatively short, and people may shed virus for a day or so,” says Arnold Monto, an epidemiologist at the University of Michigan who chairs the FDA’s Vaccines and Related Biological Products Advisory Committee, which helps make decisions on approving new vaccines. “We can infect a ferret with flu and they get sick, but if they’re not coughing or doing whatever ferrets do when they’re symptomatic, they don’t transmit as well.”

The assumption that this was also true for Covid-19 provided the stitching for a lot of pandemic protection cosplay—like temperature checks and symptom surveys. “A lot of the things we did early were based on the fact that with traditional SARS, there was not a whole lot of transmission from asymptomatic individuals,” Monto says. “Symptomatic people tend to transmit more than asymptomatic people for respiratory infections. We think that’s probably true with Covid, but it is becoming more clear that asymptomatic people are also involved in transmission.”

The problem is, a Covid-19 vaccine that only prevents illness—which is to say, symptoms—might not prevent infection with the virus or transmission of it to other people. Worst case, a vaccinated person could still be an asymptomatic carrier. That could be bad. More younger people tend to get the virus, but more older people tend to die from it; socioeconomic status and ethnicity also have an impact on death rates. Some people have relatively light symptoms; other people have symptoms that hang on for months. And perhaps most importantly, a vaccine is the only way to reach herd immunity without a bloodbath. As politicized as the notion has become, herd immunity is essentially the sum of direct protection—what you might get if you’re vaccinated—and indirect protection, safety afforded by the fact that people around you aren’t transmitting the disease to you because they either already had the disease themselves or because they got vaccinated against it. If vaccinated people can still be asymptomatic spreaders, that means less indirect protection for the herd.

That really matters, because there isn’t enough vaccine to go around. Not yet, anyway. Some groups of people will go first. The characteristics of the available vaccines would, in a perfect world, determine who those people should be. One that only prevented illness might go first to the elderly, in whom severe illness is more likely to lead to death. One that prevented infection and transmission might go to essential workers and frontline caregivers. “Part of our worry is, we want to get it right in the early allocation phase, making sure we’re targeting the vaccine as best as you can,” says Grace Lee, a professor of pediatrics at Stanford School of Medicine and a member of the CDC’s Advisory Committee on Immunization Practices. “If the only thing it did was protect against severe disease, you’d want to look at the population that has severe disease and only use it there, and nowhere else.”

That’s almost certainly not going to be the situation. The vaccines will probably all have some effect on transmission. But right now no one knows how much, or which one is better, or for whom—because so far only AstraZeneca has even a hint of data studying the problem.

(How good is that data? Well, about that: Ann Falsey, a physician at the University of Rochester School of Medicine who’s leading the US portion of the AstraZeneca vaccine trial, told me via email that “the Oxford study press release hinted at some transmission data, but I am not privileged to that data so I really can’t offer much to say.” A few hours after this story first published, Falsey emailed to add that her study and the Oxford one "are funded and run separately.“ Spokespeople for AstraZeneca didn’t return my requests for more information. Neither did anyone at Moderna. Jerica Pitts, a spokesperson at Pfizer, did, but with nothing yet to report. “In the coming months we will test participants’ blood samples for antibodies that recognize a part of the virus that is not in the vaccine. If fewer participants in the vaccine group than in the placebo group develop such antibodies, we will have evidence that the vaccine can prevent infection as well as disease,” Pitts wrote me in an email. “We do not yet have those data.”)

Different levels of protection against transmission could make a big difference in how well a vaccine will tamp down the pandemic. As part of the work of the vaccines committee that Lee is on, disease modelers spun out scenarios for the use of a vaccine that stopped 95 percent of transmission, versus one that stopped no transmission at all. (You can see some of the results starting on the 19th slide in this deck.) Given to high-risk adults and people older than 65 when incidence of the disease is rising, a vaccine that blocked infection (and therefore also transmission) could avert twice as many deaths as one that kept people from getting sick but allowed transmission.

That’s a model; in real life the differences won’t be so stark, because all the vaccines will almost certainly have some effect on transmission. The fact is, no one’s really sure how asymptomatic transmission works. It might be due to “expiratory particles” given off during talking and breathing, so maybe a vaccine that reduces symptoms would also reduce that. Or maybe just cutting down a person’s “viral load,” or the amount of virus they are carrying, also cuts the amount they can transmit. Maybe a vaccine that confers mucosal immunity, keeping the snot in someone’s nose and lungs free of virus, would lessen how much that person can send virus spreading into the universe. “Big-picture principle stuff would be: It’d be great if it eliminated transmission by eliminating asymptomatic carriers,” Lee says. “It would be great, if that weren’t true, for it to reduce your viral load, and that would in essence reduce your transmissibility.”

This wouldn’t be the first time that different vaccines had different effects. Some researchers have hypothesized that a recent resurgence of pertussis—whooping cough, a respiratory bacterial infection—might be due to a switch to a new vaccine that doesn’t address asymptomatic transmission. (That’s not the only hypothesis, but just stick with me for a second.) A model built by Sam Scarpino, director of the Emergent Epidemics Lab at Northeastern University, suggested that a switch back to the old formulation would lead to a significant drop in deaths and illnesses. Given the speed and severity of the Covid-19 pandemic, the importance of this effect could be even greater. “Especially in a country like the US with so much vaccine hesitancy, and coupled with how severe the disease can be especially in older adults, transmission block is a huge deal,” Scarpino says. “We don’t have any reason to think the Pfizer and Moderna vaccines won’t block transmission. It’s just not what has actually been measured, and something we aren’t likely to find out until we either start mass vaccination and/or they release more detailed information on the study locations—and epidemiologists start looking for effects of herd immunity.”

This absence of data on transmission was, to be clear, on purpose. The FDA laid out to vaccine makers what it was going to be looking for back in the summer, when the pandemic looked like it was peaking and hospitals were full of people on ventilators. The most important problems to focus on were severe illness and safety—because back then researchers were worried about the possibility of antibody-dependent enhancement, a rare side effect of viral illnesses in which vaccine-made tweaks to the immune system could actually cause worse problems later. And remember that Covid testing shortage? It applied to people in vaccine trials, too, which made it hard to do the kind of regular infection checks that the AstraZeneca UK wing was apparently able to do.

Which means nobody yet has transmission data beyond AstraZeneca’s vague hints. That’s suboptimal. The millions of people who may well start getting vaccinated as soon as December will also be a kind of Phase IV trial, an aftermarket test group in which scientists can observe what the vaccine does to transmission of the disease in the real world. “I do think we’re going to need that information over time,” Lee says. “But I feel like in this part of the pandemic, given the context we’re living in right now, it does feel like making vaccination a key component of protection of the population is going to be an important tool.”

It’d be better for planning to have that information in advance. But it’s not a deal breaker. “Could we refine that tool to optimize getting data? Yes, absolutely. Are we going to have that data? No. Are we going to stop and wait for that data? No,” Lee says. “Clearly, at this point the benefits of being able to protect part of the population are going to outweigh the downsides of not having perfect information.” Just because the news isn’t all good doesn’t mean it isn’t actionable.

https://www.wired.com/story/does-the-astrazeneca-vaccine-also-stop-covid-transmission/

Over 400,000 Russian Army personnel to be vaccinated against COVID-19

  Over 400,000 Russian Army personnel will be vaccinated against the novel coronavirus, Defense Minister Sergei Shoigu said on Friday.

"In compliance with the president’s instruction, vaccination of the Armed Forces personnel against the coronavirus infection has begun. Overall, over 400,000 military servicemen will be vaccinated," Shoigu said at the ministry’s board meeting.

To date, over 2.500 servicemen have been vaccinated. The number of those vaccinated will grow to 80,000 by the end of this year," the defense chief said.

Military specialists are carrying out research into the use of the plasma of vaccinated servicemen with a high level of antibodies for the treatment of the coronavirus infection, the defense minister said

"The use of this methodology has shown its efficiency for severe forms of the disease. Currently, over 500 vaccinated servicemen are involved in the research," Shoigu said.

https://tass.com/defense/1228729

Gout drug Colchicine to be tested as COVID-19 treatment in UK trial

 Anti-inflammatory colchicine will be tested as a possible COVID-19 treatment in one of the world’s biggest trials, the study website posted on Friday, the latest effort to repurpose existing medicines to fight the pandemic.

The RECOVERY trial, which is the world’s largest clinical trial of treatments for patients hospitalised with COVID-19, will randomly allocate at least 2,500 patients recruited to receive colchicine, which is used as a treatment for gout.

“Colchicine is an attractive drug to evaluate in the RECOVERY trial as it is very well understood, inexpensive and widely available,” SAID Oxford University Professor Peter Horby, who is co-chief investigator for the trial.

Colchicine costs about $124 for 30 capsules on the drugs.com website.

The scientists behind the trial said inflammation plays a major role in COVID-19 and treatment with dexamethasone, another anti-inflammatory drug, has already shown that it can reduce deaths in the most severely ill patients.

Earlier this month, one of Britain’s biggest trials also evaluated painkiller aspirin as a possible treatment for COVID-19, assessing whether it might reduce the risk of blood clots in people with the disease.

Other treatments being tested in the RECOVERY trial include common antibiotic azithromycin and the Regeneron antibody cocktail that was used to treat U.S. President Donald Trump’s COVID-19 symptoms.

https://www.reuters.com/article/health-coronavirus-recovery/gout-drug-colchicine-to-be-tested-as-covid-19-treatment-in-uk-trial-idUSKBN2870WX

Britain asks regulator to assess Oxford/AstraZeneca COVID-19 vaccine for temp use

 

Britain on Friday asked its medicine regulator to assess Oxford University and AstraZeneca's COVID-19 vaccine candidate for temporary supply, a step towards beginning a roll-out before the end of the year.

AstraZeneca expects 4 million doses to be available in Britain by the end of next month, and health minister Hancock is targeting the roll-out to begin before Christmas.

"We have formally asked the regulator to assess the Oxford/AstraZeneca vaccine, to understand the data and determine whether it meets rigorous safety standards," Hancock said in a statement.

"This letter is an important step towards deploying a vaccine as quickly as safely possible."

Britain's Medicines and Healthcare products Regulatory Agency (MHRA) is already assessing the vaccine in a "rolling review" as data comes in on safety and efficacy.

Hancock has also asked the MHRA to approve the Pfizer/BioNTech candidate after it was shown to be 95% effective.

Oxford and AstraZeneca published interim efficacy results on Monday, which showed that the vaccine could be 90% effective when given as a half dose followed by a full dose.

Questions have been raised about the Oxford/AstraZeneca data and the robustness of that result, though the MHRA approved the use of the half-dose/full-dose regime a subgroup received in the trial.

Britain's top science adviser said on Thursday that the interim results showed the Oxford/AstraZeneca vaccine worked.

"The headline result is the vaccine works and that's very exciting," Patrick Vallance said during a news conference with Prime Minister Boris Johnson. Chief Medical Officer Chris Whitty said it was up to the regulator to make an assessment.

https://www.marketscreener.com/quote/stock/ASTRAZENECA-PLC-4000930/news/AstraZeneca-Britain-asks-regulator-to-assess-Oxford-AstraZeneca-COVID-19-vaccine-31873912/

India pharma firm to make Russia's Sputnik V COVID-19 vaccine

 

Indian pharmaceutical company Hetero will manufacture over 100 million doses of the Russian Sputnik V COVID-19 vaccine per year under the terms of a deal unveiled on Friday between it and Russia's RDIF sovereign wealth fund.

The move, which RDIF cast as another step in its efforts to scale up international manufacturing of its flagship vaccine, will see Hetero begin production in India at the start of next year, according to a joint statement on the Sputnik V Twitter account.

The statement said Phase II-III clinical trials were still under way in India, which with a population of over 1.3 billion is the second most populated country in the world after China.

Although Russian authorities gave Sputnik V their regulatory approval under an accelerated procedure in August, trials in Russia, designed to assess its safety and efficacy, are also ongoing.

"While we look forward to the clinical trial results in India, we believe that manufacturing the product locally is crucial to enable swift access to patients," said B. Murali Krishna Reddy, Hetero's director of international marketing.

He said the deal chimed with an objective being promoted by the Indian prime minister of making things in India.

India's tally of COVID-19 infections stands at 9.27 million, the second-highest in the world after the United States, with more than 135,000 deaths in the south Asian nation.

Its economy, like others, has been hard hit by the virus.

Another Indian drugmaker, Dr Reddy's Laboratories Ltd, is conducting clinical trials of Sputnik V in India, and has said it expects late-stage trials to be completed by March 2021.

RDIF has spoken of Dr Reddy's being involved with distribution once Sputnik V gets regulatory approval in India.

Kirill Dmitriev, RDIF head, said earlier this week that Moscow and its foreign partners had the capacity to make more than a billion doses of Sputnik V starting from next year -- enough to vaccinate over 500 million people -- and that it would cost under $20 per person on international markets.

Friday's joint statement said Sputnik V Phase III clinical trials were also under way in Belarus, the UAE, Venezuela and other countries.

RDIF and the Gamaleya National Center said on Tuesday that interim clinical trial data had shown that Sputnik V was 91.4% effective on day 28 and over 95% effective on day 42.

https://www.marketscreener.com/quote/stock/DR-REDDY-S-LABORATORIES-6492671/news/Pharma-firm-in-India-to-make-Russia-s-Sputnik-V-COVID-19-vaccine-31874371/

Suspected North Korean hackers targeted COVID vaccine maker AstraZeneca

 

Suspected North Korean hackers have tried to break into the systems of British drugmaker AstraZeneca in recent weeks, two people with knowledge of the matter told Reuters, as the company races to deploy its vaccine for the COVID-19 virus.

The hackers posed as recruiters on networking site LinkedIn and WhatsApp to approach AstraZeneca staff with fake job offers, the sources said. They then sent documents purporting to be job descriptions that were laced with malicious code designed to gain access to a victim's computer.

The hacking attempts targeted a "broad set of people" including staff working on COVID-19 research, said one of the sources, but are not thought to have been successful.

The North Korean mission to the United Nations in Geneva did not respond to a request for comment. Pyongyang has previously denied carrying out cyberattacks. It has no direct line of contact for foreign media.

AstraZeneca, which has emerged as one of the top three COVID-19 vaccine developers, declined to comment.

The sources, who spoke on condition of anonymity to discuss non-public information, said the tools and techniques used in the attacks showed they were part of an ongoing hacking campaign that U.S. officials and cybersecurity researchers have attributed to North Korea.

The campaign has previously focused on defence companies and media organisations but pivoted to COVID-related targets in recent weeks, according to three people who have investigated the attacks.

Cyberattacks against health bodies, vaccine scientists and drugmakers have soared during the COVID-19 pandemic as state-backed and criminal hacking groups scramble to obtain the latest research and information about the outbreak.

Western officials say any stolen information could be sold for profit, used to extort the victims, or give foreign governments a valuable strategic advantage as they fight to contain a disease that has killed 1.4 million people worldwide.

Microsoft said this month it had seen two North Korean hacking groups target vaccine developers in multiple countries, including by "sending messages with fabricated job descriptions." Microsoft did not name any of the targeted organisations.

South Korean lawmakers said on Friday that the country's intelligence agency had foiled some of those attempts.

Reuters has previously reported that hackers from Iran, China and Russia have attempted to break into leading drugmakers and even the World Health Organisation this year. Tehran, Beijing and Moscow have all denied the allegations.

Some of the accounts used in the attacks on AstraZeneca were registered to Russian email addresses, one of the sources said, in a possible attempt to mislead investigators.

North Korea has been blamed by U.S. prosecutors for some of the world's most audacious and damaging cyberattacks, including the hack and leak of emails from Sony Pictures in 2014, the 2016 theft of $81 million from the Central Bank of Bangladesh, and unleashing the Wannacry ransomware virus in 2017.

Pyongyang has described the allegations as part of attempts by Washington to smear its image.

https://www.marketscreener.com/quote/stock/ASTRAZENECA-PLC-4000930/news/Exclusive-Suspected-North-Korean-hackers-targeted-COVID-vaccine-maker-AstraZeneca-sources-31876186/